Flanil (Flurbiprofen) Should Not Be Used in a 4-Year-Old Child
Flurbiprofen is not approved for use in children under 12 years of age, and there is insufficient safety and efficacy data to support its use in a 4-year-old. 1
Why This Age Restriction Exists
The evidence base for NSAIDs in young children is limited to specific agents that have undergone pediatric safety studies:
- Ibuprofen is the only NSAID approved for children aged ≥3 months, making it the standard of care for anti-inflammatory treatment in young children 2
- Flurbiprofen lacks pediatric dosing guidelines, safety data, and efficacy studies in children under 12 years 3
- The comprehensive review of NSAID safety in infants and young children does not include flurbiprofen among the agents with documented pediatric use 1
Safe Alternatives for a 4-Year-Old
For inflammatory conditions, pain, or fever in a 4-year-old, ibuprofen is the appropriate first-line NSAID:
- Ibuprofen has an established safety profile in children as young as 1 month, with extensive clinical experience 4
- The safety profile of ibuprofen in children under 2 years is consistent with its excellent profile in older children 4
- Ibuprofen remains the drug of first choice for inflammatory pain in children 2
Important Safety Considerations for Any NSAID Use in Young Children
When using NSAIDs in young children, critical precautions include:
- Avoid NSAIDs in dehydrated children or those with diarrhea and vomiting, as dehydration significantly increases the risk of renal damage 2
- NSAIDs are contraindicated in children with wheezing, persistent asthma, or during varicella infection 2
- Treatment should use the lowest age-appropriate or weight-based dose and be kept as short as possible for acute conditions 1
- For fever alone, NSAIDs should generally not be used except in rare cases; the primary goal should be improving overall comfort rather than normalizing temperature 5
Clinical Bottom Line
Use ibuprofen, not flurbiprofen, for any indication requiring NSAID therapy in a 4-year-old. 2 Flurbiprofen lacks the necessary pediatric safety data and regulatory approval for this age group, while ibuprofen has decades of proven safety and efficacy in young children. 1, 4